Abstract This supplement will support ACTIV-2D ACTIV-2D is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with SARS-CoV-2 infection. The protocol is a phase III multicenter, randomized, double blind trial to evaluate the safety and efficacy of S-217622 for the treatment of symptomatic high-risk non-hospitalized adults with SARS-CoV-2 infection. The primary outcome is to determine if the investigational agent (S-217622) will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study Day 29. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe coronavirus disease 2019 (COVID-19) during the COVID-19 pandemic.

Project Narrative The outbreak of SARS-CoV-2 across the globe presents an unprecedented health risk to the world’s population and requires intensive study of key gaps in our understanding of the immune response and what adaptations lead to protective immunity. In this study, we use a randomized, controlled platform to evaluate the safety and efficacy of S-217662 for the treatment of symptomatic high risk non-hospitalized adults with SARS-CoV-2.